Single Use 3-Lumen Sphincterotome V KD-V411M-0320 (UDI 04953170382604)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170382604), received between Oct 1, 2020 and Jan 27, 2025 — classified as 1 death, 33 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246284 ↗
• MalfunctionDec 13, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924798 ↗
• MalfunctionNov 24, 2024Break; Break

  IT WAS REPORTED DURING SEDATION FOR A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE THAT THE KNIFE WIRE OF THE SUBJECT DEVICE WAS BROKEN WHEN ENERGIZED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768023 ↗
• MalfunctionNov 24, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED, THE SUBJECT DEVICE HAD THE KNIFE BROKEN, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768007 ↗
• MalfunctionOct 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, DURING A THERAPEUTIC PROCEDURE THE LUMEN SPHINCTEROTOME V WAS TAKEN OUT, THE KNIFE WAS NOT ORIENTED CORRECTLY FROM THE BEGINNING. THE BLADE OF THE KNIFE WAS BENT. IT WAS REPLACED WITH A SIMILAR PRODUCT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO HEALTH PROBLEMS DUE TO THIS INCIDENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415615 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE WIRE OF THE SINGLE USE 2-LUMEN SPHINCTEROTOME BROKE WHEN ELECTRICITY WAS APPLIED, IT WAS CONFIRMED THAT THE DEVICE DID NOT FALL INTO THE PATIENT'S BODY. THE ISSUE OCCURRED DURING A THERAPEUTIC PAPILLOTOMY OF THE DUODENUM, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407116 ↗
• MalfunctionOct 3, 2024Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE KNIFE WIRE WAS NOT FACING THE 11 O'CLOCK DIRECTION. THE ISSUE OCCURRED DURING A THERAPEUTIC UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363675 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE'S KNIFE WIRE WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A ENDOSCOPIC SPHINCTEROTOMY PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224157 ↗
• MalfunctionAug 14, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE KNIFE OF THE SINGLE-USE 2-LUMEN SPHINCTEROTOME BROKE AFTER THE FIRST ELECTRICAL CURRENT WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC BILIARY ENDOSCOPIC SPHINCTEROTOMY. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE, WITH NO FALL-OUT OF THE BROKEN PART WITHIN THE BODY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984913 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD THE KNIFE BREAK WHEN THE WIRE WAS TIGHTENED BEFORE ELECTRICITY WAS APPLIED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) THERAPEUTIC PROCEDURE DURING THE INITIAL USE OF THE DEVICE. THERE WAS NO DELAY FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904959 ↗
• MalfunctionJul 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE EXHIBITED A SPARK AND BROKE. THE ISSUE OCCURRED DURING A ENDOSCOPIC SPHINCTEROTOMY THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746738 ↗
• MalfunctionJul 9, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS INSERTED UP TO THE NIPPLE AREA, IT WAS VISIBLE THROUGH THE MONITOR AND THE INSULATION WAS PEELING OFF SO THE DEVICE WAS REMOVED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702798 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT A SPARK OCCURRED, AND THE LUMEN SPHINCTEROTOME'S KNIFE WIRE WAS BROKEN WHEN THE DOCTOR APPLIED A HIGH-FREQUENCY OUTPUT, BUT IT DID NOT FALL OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378829 ↗
• MalfunctionMay 21, 2024Break; Break

  THE PROCEDURE WAS COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358755 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME KNIFE WIRE BROKE (WHEN ELECTRICITY WAS APPLIED). THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC PAPILLOTOMY PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323979 ↗
• MalfunctionFeb 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE SPHINCTEROTOME KNIFE WHEN INSERTED THROUGH THE ENDOSCOPE DID NOT FACE THE 11 O¿CLCOCK DIRECTION. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773853 ↗
• DeathFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE ON (B)(6) 2023. THE ENDOSCOPIC PAPILLARY LARGE BALLOON DILATATION (EPLBD) WAS PERFORMED OVER A WEEK LATER ((B)(6) 2024). ALTHOUGH THE ESTIMATED BLOOD LOSS WAS NOT PROVIDED, THE BLEEDING WAS DESCRIBED AS ¿MAJOR¿ AND OCCURRED NEAR THE PATIENT¿S NIPPLE. THE PATIENT¿S CAUSE OF DEATH WAS HEMORRHAGE. AN AUTOPSY WAS NOT PERFORMED. THE SUBJECT DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18689317 ↗
• MalfunctionJan 11, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING PREPARATION FOR USE, (4) SPHINCTEROTOME (KNIFE WIRE) FROM THE SAME LOT WERE FOUND TO HAVE AN INCORRECT ORIENTATION. THE KNIFE WIRES ARE NOT FACING THE 11 O'CLOCK DIRECTION. THE UNSPECIFIED PROCEDURE WAS COMPLETED USING A SIMILAR REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE KNIFE WIRE WAS DAMAGED, AND THE WIRE COATING WAS TORN. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18497310 ↗
• MalfunctionJan 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V DID NOT WORK. THERE WAS NO OUTPUT FAILURE, BUT THE CUTTING WIRE COULD NOT MOVE. THE ISSUE OCCURRED DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE WIRE COATING WAS TORN AND THE KNIFE WIRE WAS EXPOSED. THE REPORT IS BEING SUBMITTED DUE TO DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482055 ↗
• MalfunctionJan 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS CURLED UP IN THE ENDOSCOPIC IMAGE. THE ISSUE OCCURRED WHEN THE DEVICE WAS INSERTED INTO AN ENDOSCOPE AND ATTEMPTED TO BE USED DURING A PROCEDURE. USE OF THE DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481651 ↗
• MalfunctionDec 22, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE LUMEN SPHINCTEROTOME V, THE COATING ON THE ENDOSCOPIC SPHINCTEROTOMY KNIFE HAD PEELED OFF. THE EVENT WAS FOUND DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH ANOTHER MODEL OF THE SAME MODEL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383804 ↗
• MalfunctionOct 6, 2023Break; Break

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC PAPILLOTOMY OF THE DUODENUM, THE KNIFE WIRE TIP BROKE WHEN THE ELECTRICITY WAS TURNED ON FOR A SECOND TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886850 ↗
• MalfunctionSep 14, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD THE TIP KNIFE WIRE BREAK AT THE FIRST ENERGIZATION. THE ISSUE OCCURRED DURING THE THERAPEUTIC BILIARY ENDOSCOPIC SPHINCTEROTOMY WHICH WAS COMPLETED BY REPLACING THE SAME PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746794 ↗
• MalfunctionJun 7, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON BEHALF OF THE CUSTOMER, AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, THAT UPON OPENING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE CUSTOMER FOUND THAT THE COATED PART OF THE TIP KNIFE WAS SPLIT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ENDOSCOPIC SPHINCTEROTOMY (ERCP EST). THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA, THE PROCEDURE WAS VERY BRIEFLY DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084134 ↗
• MalfunctionApr 27, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE KNIFE WIRE BROKE WHEN THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS ENERGIZED USING THE ELECTROSURGICAL GENERATOR. THE ISSUE OCCURRED DURING ENDOSCOPIC SPHINCTEROTOMY (PAPILLARY INCISION) PROCEDURE. THE HIGH FREQUENCY CAUTERIZATION POWER SUPPLY USED WAS ESG-100. IT TOOK ABOUT ONE MINUTE TO INCISE AND BREAK. THE OUTPUT MODE WAS INCISION. THE AVERAGE ENERGIZATION TIME FOR EACH MODE WAS SEVERAL SECONDS. IT WAS ALSO REPORTED THAT THE KNIFE WIRE WAS BENT WHEN EJECTED FROM THE FORCEPS CHANNEL OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823806 ↗